MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Model Number N/A

Device Problem Incomplete Coaptation (2507)

Patient Problems Fever (1858); Renal Failure (2041); Respiratory Failure (2484); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 08/09/2022

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Dates estimated.The udi number is not known as the part and lot number were not provided.The additional patients referenced in the article are filed under a separate medwatch report number.

Event Description

This is filed to report single leaflet device attachment (slda) and all serious injuries.It was reported in a research article that a patient underwent transcatheter edge-to-edge repair (teer) for severe mitral regurgitation (mr) with grade of 4+ due to complete rupture of the posteromedial papillary muscle with flail on the anterior (a2, a3) and posterior (p3) scallops.Three xtr mitraclips were implanted across the a3-p3 and a2-p2 scallops, reducing the mr to grade of 1+.The patient¿s postprocedural course was complicated by the need for hemodialysis, continued vasopressors, persistent fevers, and a lack of cognitive response despite sedation interruption.On postprocedural day 7, the patient¿s hemodynamic and respiratory status deteriorated; a transthoracic echocardiogram (tte) revealed moderate-to-severe mr and single-leaflet device attachment (slda) of one of the clips.Given the patient¿s lack of cognitive function, the patient was transitioned to comfort care, and expired on hospital day 8.The slda may have contributed to worsening heart failure; however, the patient had an anoxic brain injury, and care was withdrawn.Per the article, mortality was unrelated to the device or procedure.Details are listed in the attached article titled, "transcatheter edge-to-edge repair for acute mitral regurgitation due to postinfarction papillary muscle rupture." no additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) and similar incident reviews were not performed because no lot information was provided.Based on available information, the cause of the reported incomplete coaptation was unable to be determined.The reported recurrent mr is a cascading event of the slda.The cause of the fever, renal failure, respiratory failure, heart failure, and unrelated death was unable to be determined.The reported patient effect of fever, renal failure, respiratory failure, death, heart failure and mitral regurgitation, as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.The reported hospitalization and unexpected medical intervention were the result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15396360
• MDR Text Key: 299665994
• Report Number: 2135147-2022-01091
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/09/2022
• Supplement Dates Manufacturer Received: 09/23/2022
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male